Director, Quality Compliance

The Director of QA Compliance, you will lead and manage all aspects of Quality Compliance. This includes overseeing Quality Systems (incident resolution, CAPAs, change control, complaint resolution), hosting FDA inspections, and responding to inspection queries. You will also oversee site-wide compliance improvements, conduct internal and external audits, ensure sustainable cGMP compliance, and draft responses to FDA observations.

Key Responsibilities:

• Guide and manage cGMP Compliance at the site, ensuring all regulations are met.
• Utilize your in-depth knowledge of 21CFR, ICH, and USP to interpret and apply regulatory standards to cGMP Operations.
• Act as the department's representative in high-level discussions and investigations with external stakeholders, including customers, vendors, and FDA representatives.
• Serve as the primary Quality representative during FDA inspections and audits by external regulators and business partners.
• Perform Compliance GAP analyses and provide recommendations for closing gaps, implementing solutions, and verifying their effectiveness.
• Develop and execute site-wide remediation and improvement plans based on assessments of Quality metrics.
• Monitor and analyze Quality metrics to maintain compliance at the site.
• Establish effective systems, processes, and cross-functional teams to manage site compliance.
• Lead and mentor direct reports, setting clear expectations and resolving conflicts.
• Ensure adherence to company protocols and timely resolution of any deviations from procedures or cGMP requirements.
• Collaborate with various departments on quality issues, audits, and special projects.
• Offer guidance to manufacturing on Quality cGMP issues to ensure compliance with standards and regulations.
• Provide technical expertise for personnel training, handling deviations, CAPA, inventory management, cGMP compliance, and data trending.
• Review and approve Out of Specifications (OOS), Standard Operating Procedures (SOPs), protocols, and investigations as needed.
• Oversee and coordinate data collection for product reviews.
• Prepare and review documentation required for regulatory submissions.
• Participate in the Quality Task Force and contribute to the creation and review of company SOPs.
• Train and develop direct reports to stay current with technology related to cGMP Compliance.

Requirements:

• Education: BA/BS in Biochemistry, Chemistry, or a related field (advanced degree preferred).
• Experience: 10+ years of experience in Quality within the biotech or pharmaceutical industry - ideally within a generic pharmaceutical organization and 7 years of leadership experience
• Strong Preference: Oral Solid Dosage Manufacturing experience.
• Skills: experienced in managing and hosting regulatory inspections, strong communication and leadership skills with transparency, and capability of leading the department for optimal performance and future improvements.